Second Half of 2015 Nexgard and Bravecto ADE Reports

I am so pleased to say that my 01/06/16 FOIA request for Bravecto/Nexgard Adverse Drug Event reports has been fulfilled! This is record timing compared to the last request, which took 5 months. As anticipated, there were a large number of reports during the time period encompassing 06/18/15 – 01/06/16, as follows:

Afoxolaner (Nexgard): 2,048 reports

Fluralaner (Bravecto): 2,852 reports

This is compared to the previous report I received in November 2015, encompassing 1/1/13 – 06/17/15:

Afoxolaner (Nexgard): 5,087

Fluralaner (Bravecto): 2,467

I’d like to gently remind you of the following points as you read these reports. This information is taken from the first two pages, and it’s important to view all of this data with these things in mind.

The Center for Veterinary Medicine (CVM) states “The primary purpose for maintaining the CVM ADE database is to provide an early warning or signaling system to CVM for adverse effects not detected during pre-market testing of FDA approved animal drugs and for monitoring the performance of drugs not approved for use in animals. CVM’s ADE reporting system depends on detection and voluntary reporting of adverse clinical events by veterinarians and animal owners.”

“Clinical signs reported for an active ingredient are listed in order from most frequently reported to least frequently reported, grouped by species and route of administration.”

“More than one clinical sign may have been reported per ADE case report, so the ‘Number of times reported’ column is not additive and does not necessarily represent the total number of reports received.”

“For any given ADE report, there is no certainty that the reported drug caused the adverse event. The adverse event may have been related to an underlying disease, using other drugs at the same time, or other non-drug related causes. The clinical detail listing does not include information about underlying diseases, other drugs used at the same time, other non-drug related causes, or the final outcome of the reaction.”

“The accuracy of information regarding the ADE is dependent on the quality of information received from the reporting veterinarian or animal owner.”

“Accumulated ADE reports should not be used to calculate incidence rates or estimates of drug risk, because there is no accurate way to determine how many animals were given the drug, which is needed as the denominator in calculations of incidence and relative risk.”

“It is inappropriate to make use of adverse event data to compare the safety of different products. For example, if a drug is widely used to treat certain conditions, there may be more ADEs for that drug than another product that is not used as often. This would not mean that the first drug was more unsafe than the second.”

“Underreporting occurs with most adverse event reporting systems. The frequency of reporting for a given drug product varies over time, and may be greater when the drug is newly marketed, or when media publicity occurs.”

Comments

My 3yr old healthy male English Bulldog, Bubba, took his first Nexgard on July 7,2016. Today, he is inpatient with acute liver failure. Initial symptoms led us to think obstruction, poor appetite, sore belly, excessive panting, drooling, pacing. Then the vomiting started. First vet trip was 7/19/16 for overnight hydration. Was better and sent home 7/20/16. Began to decline and back on 7/21/16. Proceeded with surgery for what we believed to be an obstruction and Dr found the liver very enlarged and sick. Knowing now her has something wrong with his liver, i recall trying to wipe something yellow off of his belly about a week or so ago. I’m guessing now it was jaundice. I’m praying he recovers.

I am so sorry to read this, Angela. I see from the Facebook group that he is now home and is taking Denamarin. I do hope he continues to recover!! If you/your vet haven’t done so, please report this to Merial/FDA. Every single report is so important. Sending healing thoughts…

I gave my 6 year old schnauzer, Izzie, nexgard 4 days ago. She is now refusing to eat, throwing up and direrria. I am very worried. Because its Sunday, I’m taking her to the vet in the morning. She has always been a healthy happy girl and I was only given one dose. The vet office didn’t tell me about the side affects or give me information about this drug.

So sorry your Izzie wasn’t feeling well! I hope she is on the mend by now. Vomiting, diarrhea, and lack of appetite are listed on the product insert as potential side effects. If your vet hasn’t already done so, please consider reporting this to the manufacturer and FDA. Every report made is important so we can assess the overall safety profile of this drug. Sending healing thoughts!

Our Ava started with a foul smell coming from her mouth (but was not her breath) vomiting and lethargy. I have tried to contact the nexguard company without success. She was otherwise healthy, almost 2 yrs old and we just switched to the nexguard! I pray she heals from this!

I am so sorry to read about Ava’s illness. Merial’s number is 1-888-637-4251. You can also file your own report following instructions at this link. Have you talked to your veterinarian about Ava’s illness? He or she should be able to reach out quickly to Merial on your behalf, as well as offer some treatment options to help Ava. As you probably know, there is nothing we can do to counteract the effects of Nexgard, but other dog owners have used a detox protocol (usually involving milk thistle) to help their dogs more effectively deal with the drug. You can search for a veterinarian in your area to help you with detox by clicking this link. Sending healing thoughts for Ava’s quick recovery!

Oh no!!! Was this the first dose of Bravecto your dog had ever taken? If you are on Facebook, please look at this group, where there is a lot of support and assistance available to you as you manage his illness. As you have time to do so, please talk with your vet about reporting this to Merck and FDA. Also, I am here if you need help, you may email me directly at drcarney@yourpetsneedthis.com. Sending strength to you and your Sheltie!

My two year old beagle puppy had her third dose od Bravecto in January
Shortly after that she tarted limping in her front paw
She wS treated with anti inflammatory and rest which seemed to help.
About a moth later she became lame in all her legs and her body was shaking
Took her to specialty hospital. She was evaluated by a neurologist ,
Had MRI and spinal tab with blood an fluid sent away for testing
The diagnosis was immune mediated encephalitis .
She will be in drug therapy for a long time
I can’t help but think that this may have had something to do with the Bravecto
I will ever use this drug again
T

I am so very sorry to read about your Beagle’s illness after third dose of Bravecto. I believe you are the first person I have heard from who has had CSF tap and MRI with a diagnosis of immune mediated encephalitis. Do you know if the veterinarian reported this to Merck, or did you report it? If not, please do consider reporting, using this link. Were there any other abnormalities noted in her testing? Do you have a copy of her medical record from the neurologist? Sorry for all the questions – I am trying to determine a specific test or set of tests we can develop, that can be run after Bravecto use, to rule in or out whether it is causing these problems. If you’d like to share more with me, please email me at drcarney@yourpetsneedthis.com. Sending healing thoughts your way.

Yes I have all the records from the neurologist
I have not yet reported to Merck but I will
You can check out Lucy on the Animal specialty hospital ASH
They have her on their facebookpage with a video befor and after treatment
I will forward you the link

I did talk to Dr. Carnes ,the neurologist,and mentioned my concerns about the Bravecto.
She had not heard of this drug causing this but did say its relatively a new drug
I said I would never use again and she said she agreed…once given it is in their system for 3 months
To me,itmust be a pretty potent drug to be in your system for 3 months killing ticks and fleas!

Hundreds of neurologic signs, including seizures, disorientation, ataxia,and tremors, have been reported to FDA and EMA following use of Bravecto. I am glad you spoke to her about it and hopefully it will be on her radar screen in the future. Very potent indeed. I wonder why we develop drugs for our dogs that we would never be willing to take ourselves?